Flaskworks is moving forward to complete validity tests for the commercial grade unit version and then once approved, to commercially manufacture and ultimately transition from commercial artisan manufacturing to commercial grade automated closed system manufacturing — aka: Eden.
There is a point in the development process where formal validation must still occur but is really mostly just a formality where an entire fitting out is done inspected and approved for commercial use. The original product is basically green lighted much earlier. We have the green light based on the actions NWBO is taking but the fitting out still takes a while as explained in the PR about components of the clean rooms having long lead times. Afterwards comes final inspection. In the mean time, the B grade clean rooms can be used for initial commercialization purposes which is what the MIA was based on and likely where comparability/equivalence tests were performed. Best wishes.
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